Peter S. Hall, Ph.D.
Comparative efficacy and associated adverse events (AEs) were seen with a lower dose of Eloxatin and Xeloda in elderly and vulnerable patients with advanced gastrointestinal cancer, according to results presented at the American Society of Oncology (ASCO 2019) annual meeting.
Peter S. Hull, PhD, lead author of GO2, said that the average age at which a UK patient is diagnosed with advanced gastric cancer is about 75 years old, and many of these patients experience fragility or comorbidities.
"The standard chemotherapy for these patients has been developed on a number of historical clinical trials that mostly involved younger patients at the age of about 65, who are usually free of medical attendant diseases and were selected to be without fragility," said Hall, Lecturer Clinical major in cancer and health economics at the University of Edinburgh.
As a result, many elderly or vulnerable patients with advanced gastro esophageal cancer are treated with a wide range of non-evidence-based chemotherapy systems, Hall explained. In the previous researcher's 321GO experiment, a standard 3 drug system was compared with 2 drugs and 1 drug system for this patient population.
We have found that the Medicines 2 system contains the best balance between benefits and damage in that second phase of the experiment. Therefore, we concluded that the 2-drug system in the preparation of a large experiment, the third phase called GO2, which was a national experiment conducted in the UK aims to find optimal dose levels of this system, especially in vulnerable or elderly patients, Damages and benefits, "Hall said.
GO2 was a Phase III randomized trial designed to find the ideal dose of oxaliplatin, which inhibits DNA proliferation, as well as capicetabine, which inhibits the division of cancer cells. Investigators also investigated optimal clinical utility, endurance, quality of life, and patient satisfaction for dual drug identification for a comprehensive treatment tool (OTU).
The participants ranged in age from 51 to 96 years, and were randomized to one of three dose levels: Level A, 130 mg / m2 Of oxaliplatin is administered once ever 21 days and 625 mg / m2 Of capecitabine twice a day, given continuously. Level B, which was 80% of the A level dose; and the C level, which was 60% of the A level dose. Patients received renal function decreased 75% of the proposed dose of capecitabine.
PFS – the primary end point – was comparable between groups, in 4.9 months, 4.1 months and 4.3 months for levels A, B and C, respectively.
After 9 weeks, the researchers found that patients randomized to the C dose had less toxic reactions and OTU results were better than those in younger A and B. The less vulnerable patients tended to get better OTUs, and the group did not benefit from doses At level A, patients at level C also had a higher rate of good OTU (43%) compared with 35% at level A and 36% at level B.
To achieve a good OTU, patients had to achieve 6 different areas, including: cancer does not precede screening; severe hypoxia; global quality of life does not deteriorate; patients who register treatment as worthwhile and do not interfere in daily activities.
Survival (OS) was a secondary measure, and did not change much between the two groups either. Patients lived at an average level of 7.5 months; patients received a mean of 6.7 months on average; and patients at C level lived an average of 7.6 months.
When it comes to toxicity, more than half of the patients (56%) who receive A and B doses have had acute AE or level 3 or higher, compared to only 37% of the C level.
We found that the lowest dose tested was not low in terms of survival without progression. It has produced less toxicity and better overall therapeutic benefit. "We conclude that low-dose therapies can be offered to patients who are suitable for chemotherapy, but are considered either weak or elderly for a standard full-dose regimen, with the confidence that it can produce superior results without compromising cancer control or survival."
Hall PS, Swinson D, Waters JS, Falk S, et al. Alternative chemotherapy for vulnerable or elderly patients with advanced stomach or esophageal cancer. Presented at: 2019 Annual Meeting ASCO. May 31 – June 4, 2019; Chicago, IL. Abstract 4006.